81 FR 13371 - Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 49 (March 14, 2016)

The Food and Drug Administration (FDA, the Agency) is announcing the availability for public comment of the draft environmental assessment (EA) submitted by Oxitec Ltd. and a preliminary finding of no significant impact (FONSI) in support of the conduct of an investigational release of genetically engineered (GE) mosquitoes under an investigational new animal drug exemption.

[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13371-13372]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2235]


Draft Environmental Assessment and Preliminary Finding of No 
Significant Impact Concerning Investigational Use of Oxitec OX513A 
Mosquitoes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency) is 
announcing the availability for public comment of the draft 
environmental assessment (EA) submitted by Oxitec Ltd. and a 
preliminary finding of no significant impact (FONSI) in support of the 
conduct of an investigational release of genetically engineered (GE) 
mosquitoes under an investigational new animal drug exemption.

DATES: Submit either electronic or written comments on the draft EA by 
April 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-2235 for Draft Environmental Assessment and Preliminary 
Finding of No Significant Impact Concerning Investigational Use of 
Oxitec OX513A Mosquitoes. Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Persons with access to the Internet may 
obtain the draft EA at either http://www.fda.gov/animalveterinary/developmentapprovalprocess/environmentalassessments/ucm300656.htm or 
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brinda Dass, Center for Veterinary 
Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8247, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing that a draft EA and 
preliminary FONSI, in support of a proposed investigational release 
(i.e., field trial) of OX513A Aedes aegypti GE mosquitoes (OX513A 
mosquitoes), as part of an existing mosquito control program in Key 
Haven, FL, are being made available for public comment. The OX513A is a 
strain of Ae. aegypti mosquito whose recombinant DNA (rDNA) construct 
encodes a conditional lethality trait such that the offspring of the 
matings of male OX513A mosquitoes and wild type Ae. aegypti do not 
survive to adulthood. The intended result is a decrease in the overall 
population of Ae. aegypti in the environment. Only male OX513A 
mosquitoes are intended to be released.
    To encourage public transparency, and in compliance with 21 CFR 
25.51(b)(3), the Agency is placing Oxitec Ltd.'s draft EA and 
preliminary FONSI that are the subject of this notice on public display 
at the Division of Dockets

[[Page 13372]]

Management (see DATES and ADDRESSES) for public review and comment for 
30 days. Oxitec Ltd. prepared the draft EA. The preliminary FONSI is 
based upon Oxitec Ltd.'s draft EA. FDA is considering the draft EA and 
tentatively agrees with its conclusion that conduct of this trial will 
result in no significant impacts on the environment. If nothing changes 
FDA's tentative determination, FDA will prepare and release its own 
revised, final EA and final FONSI. The Agency intends to take comments 
received under advisement in determining whether to prepare a revised, 
final EA and FONSI. If FDA does not agree with the preliminary 
conclusion that conduct of this trial will result in no significant 
impacts on the environment, it will prepare an environmental impact 
statement.

    Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05622 Filed 3-11-16; 8:45 am]
 BILLING CODE 4164-01-P